Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…

ByRidhi RastogiDecember 15, 2025

NEWS

Sobi to Acquire Arthrosi Therapeutics for ~$1.5B

Shots: Sobi has entered into a definitive agreement to acquire Arthrosi Therapeutics, incl. its asset pozdeutinurad (AR882), expanding its gout pipeline As per the deal, Sobi will acquire Arthrosi in an all-cash transaction for $950M upfront & ~$550M in clinical, regulatory & sales milestones; closing is expected in H1’26 Pozdeutinurad (QD, PO) is an URAT1…

ByRidhi RastogiDecember 15, 2025

NEWS

Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

Shots: The US FDA has approved Zenflow Spring Implant & Delivery System, a first-line interventional therapy, for the treatment of BPH-associated symptoms Assessed in the BREEZE study, the system met all 1 & 2EPs, showing a 60% responder rate vs 33% for sham & a 37% IPSS improvement exceeding the 30% success threshold at 1yr.,…

ByRidhi RastogiDecember 12, 2025

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STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

NEWS

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Shots: The US FDA has accepted sBLA & granted priority review to BMS' Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026) sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above…

ByRidhi RastogiDecember 12, 2025

NEWS

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

NEWS

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points It also reduced known CV risk markers &…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

Shots: The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC) Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK…

ByRidhi RastogiDecember 11, 2025

NEWS

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

Shots: Health Canada has approved PTC's Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in pts (≥1mos.) with sepiapterin-responsive PKU Approval was based on APHENITY study results & long-term extension data showing durable effects & favorable safety in PKU pts Sephience is a natural precursor…

ByRidhi RastogiDecember 11, 2025

Ridhi Rastogi

Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Sobi to Acquire Arthrosi Therapeutics for ~$1.5B

Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

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